DRUGS AND COSMETICS (2ND AMENDMENT) RULES, 2006

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health) NOTIFICATION New Delhi, the 16th March, 2006 G.S.R. 160(E). Whereas a draft of certain rules further to amend the Drugs and Cosmetics Rules, 1945 was published, as required by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), dated the 24th February, 2005, under the notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health), number G.S.R. 105(E), dated the 24th February, 2005, inviting objections and suggestions from all persons likely to be affected thereby, before the expiry of a period of forty five days from the date on which copies of the Official Gazette containing the said notification were made available to the public; And whereas copies of the said Gazette were made available to the public on 25th February, 2005; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government. Now, therefore, in exercise of the powers conferred by Sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs and Cosmetics Rules, 1945, namely: 1. (1) These rules may be called the Drugs and Cosmetics (2nd Amendment) Rules, 2006. *Published in the Gazette of India (extraordinary) Part-II, section 3, sub-section (i) vide G.S.R. 160(E), dated 16th March, 2006.

(2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs and Cosmetics Rules, 1945, for Schedule H, the following Schedule shall be substituted, namely:SCHEDULE-H (See Rules 65 and 97) PRESCRIPTION DRUGS
1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40. ABACAVIR ABCIXIMAB ACAMPROSATE CALCIUM ACEBUTOL HYDROCHLORIDE ACLARUBICIN ALBENDAZOLE ALCLOMETASONE DIPROPIONATE ACTILYSE ACYCLOVIR ADENOSINE ADRENOCORTICOTROPHIC HORMONE (ACTH) ALENDRONATE SODIUM ALLOPURINOL ALPHACHYMOTRYPSIN ALPRAZOLAM ALPROSTADIL AMANTADINE HYDROCHLORIDE AMIFOSTINE AMIKACIN SULPHATE AMILORIDE HYDROCHLORIDE AMINEPTINE AMINOGLUTETHIMIDE AMINOSALICYLIC ACID AMIODARONE HYDROCHLORIDE AMITRIPTYLINE AMLODIPINE BESYLATE AMOSCANATE AMOXOPINE AMRINONE LACTATE ANALGIN ANDROGENIC ANABOLIC, OESTROGENIC & PROGESTATIONAL SUBSTANCES ANTIBIOTICS APRACLONIDINE APROTININ ORGANIC COMPOUND OF ARSENIC ARTEETHER ARTEMETHER ARTESUNATE ARTICAINE HYDROCHLORIDE ATENOLOL

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41. 42. 43. 44. 45. 46. 47. 48. 49. 50. 51. 52. 53. 54. 55. 56. 57. 58. 59. 60. 61. 62. 63. 64. 65. 66. 67. 68. 69. 70. 71. 72. 73. 74. 75. 76. 77. 78. 79. 80. 81. 82. 83. 84. 85. 86. 87. 88. 89. 90. 91. 92. 93. 94. 95. ATRACURIUM BESYLATE INJECTION ATORVASTATIN AURANOFIN AZATHIOPRINE AZTREONAM BACAMPICILLIN BACLOFEN BALSALAZIDE BAMBUTEROL BARBITURIC ACID BASILIXIMAB BENAZEPRIL HYDROCHLORIDE BENIDIPINE HYDROCHLORIDE BENSERAZIDE HYDROCHLORIDE BETAHISTINE DIHYDROCHLORIDE BETHANIDINE SULPHATE BEZAFIBRATE BICALUTAMIDE BICLOTYMOL BIFONAZOLE BIMATOPROST BIPERIDEN HYDROCHLORIDE BIPHENYL ACETIC ACID BITOSCANATE BLEOMYCIN PRIMONIDINE TARTRATE BROMHEXINE HYDROCLORIDE BROMOCRIPTINE MESYLATE BUDESONIDE BULAQUINE BUPIVA CAINE HYDROCHLORIDE BUPROPION BUSPIRONE BUTENAFINE HYDROCHLORIDE BUTORPHANOL TARTRATE CABERGOLINE CALCIUM DOBESILATE CANDESARTAN CAPECITABINE CAPTOPRIL CARBIDOPA CARBOCISTEINE CARBOPLATIN CARBOQUONE CARISOPRODOL L-CARNITINE CARTEOLOL HYDROCHLORIDE CARVEDILOL CEFADROXYL CEFATOXIME SODIUM CEFAZOLIN SODIUM CEFDINIR CEFEPIME HYDROCHLORIDE CEFETAMET PIVOXIL CEFPIROME 96. 97. 98. 99. 100. 101. 102. 103. 104. 105. 106. 107. 108. 109. 110. 111. 112. 113. 114. 115. 116. 117. 118. 119. 120. 121. 122. 123. 124. 125. 126. 127. 128. 129. 130. 131. 132. 133. 134. 135. 136. 137. 138. 139. 140. 141. 142. 143. 144. 145. 146. 147. 148. 149. CEFPODOXIME POXETIL CEFTAZIDIME PENTAHYDRATE CEFTIZOXIME SODIUM CEFUROXIME CELECOXIB CENTCHROMAN CENTBUTINDOLE CENTPROPAZINE CETIRIZINE HYDROCHLORIDE CHLORDIAZEPOXIDE CHLORMEZANONE
Omitted vide GSR 790 (E) dtd 29.10.2009

CHLORPROMAZINE CHLORZOXAZONE CICLOPIROX OLAMINE CIMETIDINE CINNARIZINE CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE / LACTATE CISPLATIN CITALOPRAM HYDROBROMIDE CLARITHROMYCIN CLAVULANIC ACID CLIDINIUM BROMIDE CLINDAMYCIN CLOBAZAM CLOBETASOL PROPENATE CLOBETASONE 17-BUTYRATE CLOFAZIMINE CLOFIBRATE CLONAZEPAM CLONIDINE HYDROCHLORIDE CLOPAMIDE CLOPIDOGREL BISULPHATE CLOSTEBOL ACETATE CLOTRIMAZOLE CLOZAPINE CODEINE COLCHICINE CORTICOSTEROIDS COTRIMOXAZOLE CYCLANDELATE CYCLOSPORINS DACLIZUMAB DANAZOLE DAPSONE DESLORATADINE DESOGESTROL DEXRAZOXANE DEXTRANOMER
Omitted vide GSR 790 (E) dtd 29.10.2009

DEXTROPROPOXYPHENE DIAZAPAM DIAZOXIDE DICLOFENAC SODIUM/POTASSIUM/ACID

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150. 151. 152. 153. 154. 155. 156. 157. 158. 159. 160. 161. 162. 163. 164. 165. 166. 167. 168. 169. 170. 171. 172. 173. 174. 175. 176. 177. 178. DICYCLOMIN HYDROCHLORIDE DIDANOSINE DIGOXINE DILAZEP HYDROCHLORIDE DILTIAZEM DINOPROSTONE DIPHENOXYLATE, ITS SALTS DIPIVEFRIN HYDROCHLORIDE DI-SODIUM PAMIDRONATE DISOPYRAMIDE DOCETAXEL DOMPERIDONE DONEPEZIL HYDROCHLORIDE DOPAMINE HYDROCHLORIDE DOTHIEPIN HYDROCHLORIDE DOXAPRAM HYDROCHLORIDE DOXAZOSIN MESYLATE DOXEPIN HYDROCHLORIDE DOXORUBICIN HYDROCHLORIDE DROTRECOGIN-ALPHA EBASTINE ECONOZOLE EFAVIRENZ ENALAPRIL MELEATE ENFENAMIC ACID EPINEPHRINE EPIRUBICINE EPTIFIBATIDE ERGOT, ALKALOIDS OF WHETHER HYDROGENATED OR NOT, THEIR HOMOLOGOUES, SALTS ESOMEPRAZOLE ESTRADIOL SUCCINATE ESTRAMUSTINE PHOSPHATE ETANERCEPT ETHACRIDINE LACTATE ETHAMBUTOL HYDROCHLORIDE ETHAMSYLATE ETHINYLOESTRADIOL ETHIONAMIDE ETIDRONATE DISODIUM ETODOLAC ETOMIDATE ETOPOSIDE EXEMESTANE FAMCICLOVIR FAMOTIDINE FENBENDAZOLE FENOFIBRATE FEXOFENADINE FINASTERIDE FLAVOXATE HYDROCHLORIDE 5-FLUOROURACIL FLUDARABINE FLUFENAMIC ACIDS 203. 204. 205. 206. 207. 208. 209. 210. 211. 212. 213. 214. 215. 216. 217. 218. 219. 220. 221. 222. 223. 224. 225. 226. 227. 228. 229. 230. 231. 232. 233. 234. 235. 236. 237. 238. 239. 240. 241. 242. 243. 244. 245. 246. 247. 248. 249. 250. 251. 252. 253. 254. 255. FLUNARIZINE HDROCHLORIDE FLUOXETINE HYDROCHLORIDE FLUPENTHIXOL FLUPHENAZINE ENANTHATE AND DECANOATE FLURAZEPAM FLURBIPROFEN FLUTAMIDE FLUTICASONE PROPIONATE FLUVOXAMINE MALEATE FORMESTANE FOSFESTRIL SODIUM FOSINOPRIL SODIUM FOSSPHENYTOIN SODIUM FOTEMUSTINE GABAPENTIN GALANTHAMINE HYDROBROMIDE GALLAMINE, ITS SALTS, ITS QUATERNARY COMPOUND GANCYCLOVIR GANIRELIX GATIFLOXACIN GEMCITABINE GEMFIBROZIL GEMTUZUMAB GENODEOXYCHOLIC ACID GLICLAZIDE GLIMEPIRIDE GLUCAGON GLYCOPYRROLATE GLYDIAZINAMIDE GOSERELIN ACETATE GRANISETRON GUANETHIDINE GUGULIPID HALOGENATED HYDROXYQUINOLINES HALOPERIDOL HEPARIN HEPATITIS B. VACCINE HYALURONIDASE HYDROCORISONE 17-BUTYRATE HYDROTALCITE HYDROXIZINE IBUPROFEN IDEBENONE IINDAPAMIDE IMIPRAMINE INDINAVIR SULPHATE INDOMETHACIN INSULIN HUMAN INTERFERON INTRAVENOUS FAT EMULSION IOBITRIDOL IOHEXOL IOPAMIDOL

179. 180. 181. 182. 183. 184. 185. 186. 187. 188. 189. 190. 191. 192. 193. 194. 195. 196. 197. 198. 199. 200. 201. 202.

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256. 257. 258. 259. 260. 261. 262. 263. 264. IOMEPROL IOPROMIDE IRBESARTAN IRINOTECAN HYDROCHLORIDE IRON PREPARATION FOR PARENTERAL USE ISEPAMICINE ISOCARBOXSIDE ISOFLURANE ISONICOTNIC ACID HYDRAZINE AND OTHER-HYDRAGINE DERIVATIVES OF ISONICOTINIC ACID ISOSORBIDE DINITRATE/ MONONITRATE ISOTRETINOIN ISOXSUPRINE ITOPRIDE KETAMINE HYDROCHLORIDE KETOCONAZOLE KETOPROFEN KETOROLAC TROMETHAMINE LABETALOL HYDROCHLORIDE LACIDIPINE LAMIVUDINE LAMOTRIGINE LATANOPROST LEFUNOMIDE LERCANIDIPINE HYDROCHLORIDE LETROZOLE LEUPROLIDE ACETATE LEVAMESOLE LEVARTERENOL LEVOBUNOLOL LEVOCETIRIZINE LEVODOPA LEVOFLOXACIN LEVOVIST LIDOFLAZINE LINEZPLID LITHIUM CARBONATE LOFEPRAMINE DECANOATE LOPERAMIDE LORAZEPAM LOSARTAN POTASSIUM LOTEPREDNOL LOVASTATIN LOXAPINE MEBENDAZOLE MEBEVERINE HYDROCHLORIDE MEDROXY PROGESTERONE ACETATE MEFENAMIC ACID MEFLOQUINE HYDROCHLORIDE MEGESTROL ACETATE MEGLUMINE IOCARMATE MELAGENINA MELITRACEN HYDROCHLORIDE 308. 309. 310. 311. 312. 313. 314. 315. 316. 317. 318. 319. 320. 321. 322. 323. 324. 325. 326. 327. 328. 329. 330. 331. 332. 333. 334. 335. 336. 337. 338. 339. 340. 341. 342. 343. 344. 345. 346. MELOXICAM MEPHENESIN, ITS ESTERS MEPHENTERMINE MEROPENAM MESTEROLONE METAXALONE METHICILLIN SODIUM METHOCARBAMOL METHOTRAXATE METOCLOPRAMIDE METOPROLOL TARTRATE METRIZAMIDE METRONIDAZOLE MEXILETINE HYDROCHLORIDE MIANSERIN HYDROCHLORIDE MICONAZOLE MIDAZOLAM MIFEPRISTONE MILRINONE LACTATE MILTEFOSINE MINOCYCLINE MINOXIDIL MIRTAZAPINE MISOPROSTOL MITOXANTRONE HYDROCHLORIDE MIZOLASTINE MOCLOBEMIDE MOMETASONE FUROATE MONTELUKAST SODIUM MORPHAZINAMIDE HYDROCHLORIDE MOSAPRIDE MOXIFLOXACIN MYCOPHENOLATE MOFETIL NADIFLOXACIN NADOLOL NAFARELIN ACETATE NALIDIXIC ACID NAPROXEN NARCOTICS DRUGS LISTED IN NARCOTIC DRUGS & PSYCHOTROPIC SUBSTANCES ACT, 1985 NATAMYCIN NATEGLINIDE N-BUTYL-2-CYANOACRYLATE NEBIVOLOL NEBUMETONE NELFINAVIR MESILATE NETILMICIN SULPHATE NEVIRAPINE NICERGOLINE NICORANDIL NIFEDIPINE NIMESULIDE NIMUSTINE HYDROCHLORIDE NITRAZEPAM

265. 266. 267. 268. 269. 270. 271. 272. 273. 274. 275. 276. 277. 278. 279. 280. 281. 282. 283. 284. 285. 286. 287. 288. 289. 290. 291. 292. 293. 294. 295. 296. 297. 298. 299. 300. 301. 302. 303. 304. 305. 306. 307.

347. 348. 349. 350. 351. 352. 353. 354. 355. 356. 357. 358. 359. 360.

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361. 362. 363. 364. 365. 366. 367. 368. 369. 370. 371. 372. 373. 374. 375. 376. 377. 378. 379. 380. 381. 382. 383. 384. 385. 386. 387. 388. 389. 390. 391. 392. 393. 394. 395. 396. 397. 398. 399. 400. 401. 402. 403. 404. NITROGLYCERIN NORETH ISTERONE ENANTHATE NORFLOXACIN OCTYLONIUM BROMIDE OFLOXACIN OLANZAPINE OMEPRAZOLE ORNIDAZOLE ORPHENADRINE ORTHOCLONE STERILE OXAZEPAM OXAZOLIDINE OXCARBAZEPINE OXETHAZAINE HYDROCHLORIDE OXICONAZOLE OXOLINIC ACID OXPRENOLOL HYDROCHLORIDE OXYBUTYNIN CHLORIDE OXYFEDRINE OXYMETAZOLINE OXYPHENBUTAZONE OXYTOCIN OZOTHINE PACLITAXEL PANCURONIUM BROMIDE PANTOPRAZOLE PARA-AMINO BENZENE SULPHONAMIDE, ITS SALTS & DERIVATIVES PARP-AMINO SALICYLIC ACID, ITS SALTS, ITS DERIVATIVES PARECOXIB PAROXETINE HYDROCHLORIDE D-PENICILLAMINE PENTAZOCINE PENTOXIFYLLINE PEPLEOMYCIN PHENELZINEH SULPHATE PHENOBARBITAL PHENOTHIAZINE, DERIVATIVES OF AND SALTS OF ITS DERIVATIVES PHENYLBUTAZINE PIMOZIDE PINDOLOL PIOGLITAZONE HYDROCHLORIDE PIRACETAM PIROXICAM PITUITORY GLAND, ACTIVE PRINCIPLES OF, NOT OTHERWISE SPECIFIED IN THIS SCHEDULE AND THEIR SALTS POLIDOCANOL POLYESTRADIOL PHOSPHATE PORACTANT ALFA PRAZIQUANTEL PREDNIMUSTINE PREDNISOLONE STEAROYLGLYCOLATE PRENOXDIAZIN HYDROCHLORIDE 412. 413. 414. 415. 416. 417. 418. 419. 420. 421. 422. 423. 424. 425. 426. 427. 428. PROMAZINE HYDROCHLORIDE PROMEGESTONE PROPAFENON HYDROCHLORIDE PROPANOLOL HYDROCHLORIDE PROPOFOL PROTRISTYLINE HYDROCHLORIDE PYRAZINAMIDE PYRVINIUM QUETIAPINE FUMERATE QUINAPRIL QUINIDINE SULPHATE RABEPRAZOLE RACECADOTRIL RALOXIFENE HYDROCHLORIDE RAMIPRIL HYDROCHLORIDE RANITIDINE RAUWOLFIA, ALKALOIDS OF, THEIR SALTS, DERIVATIVES OF THE ALKALOIDS OR RAUWOLFIA REBOXETINE REPAGLINIDE REPROTEROL HYDROCHLORIDE RILMENIDINE RILUZONE RISPERIDONE RITONAVIR RITODRINE HYDROCHLORIDE RITUXIMAB RIVASTIGMINE ROCURONIUM BROMIDE ROPINIROLE ROSOXACIN ROSIGLITAZONE MELEATE SALBUTAMOL SULPHATE SALICYL-AZO-SULPHAPYRIDINE SALMON CALCITONIN SAQUINAVIR SATRANIDAZOLE SECNIDAZOLE SEPTOPAL BEADS & CHAINS SERRATIOPEPTIDASE SERTRALINE HYDROCHLORIDE SIBUTRAMINE HYDROCHLORIDE SILDENAFIL CITRATE SIMVASTATIN SIROLIMUS SISOMICIN SULPHATE S-NEOMINOPHAGEN SODIUM PICOSULPHATE SODIUM CROMOGLYCATE SODIUM HYALURONATE SODIUM VALPROATE SODIUM AND MAGLUMINE IOTHALAMATES SOMATOSTATIN

405. 406. 407. 408. 409. 410. 411.

429. 430. 431. 432. 433. 434. 435. 436. 437. 438. 439. 440. 441. 442. 443. 444. 445. 446. 447. 448. 449. 450. 451. 452. 453. 454. 455. 456. 457. 458. 459. 460. 461. 462. 463.

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464. 465. 466. 467. 468. 469. 470. 471. 472. 473. 474. 475. 476. 477. 478. 479. 480. 481. 482. 483. 484. 485. 486. 487. 488. 489. 490. 491. 492. 493. 494. 495. 496. 497. 498. 499. 500. 501. 502. 503. 504. 505. 506. 507. 508. 509. 510. 511. 512. 513. 514. 515. 516. 517. 518. SOMATOTROPIN SOTALOL SPARFLOXACIN SPECTINOMYCIN HYDROCHLORIDE SPIRONOLACTONE STAVUDINE SUCRALFATE SULPHADOXINE SULPHAMETHOXINE SULPHAMETHOXYPYRIDAZINE SULPHAPHENAZOLE SULPIRIDE SULPROSTONE HYDROCHLORIDE SUMATRIPTAN TACRINE HYDROCHLORIDE TAMSULOSIN HYDROCHLORIDE TRAPIDIL TEGASEROD MALEATE TEICOPLANIN TELMISARTAN TEMOZOLAMIDE TERAZOSIN TERBUTALINE SULPHATE TERFENADINE TERIZIDONE TERLIPRESSIN TESTOSTERONE UNDECOANOATE TERATOLOL HYDROCHLORIDE THALIDOMIDE THIACETAZONE THIOCOLCHICOSIDE THIOPROPAZATE, ITS SALTS THYMOGENE THYMOSIN-ALPHA 1 TIAPROFENIC ACID TIBOLONE TIMOLOL MALEATE TINIDAZOLE TIZANIDINE TABRAMYCIN TOLFENAMIC ACID TOPIRAMATE TOPOTECAN HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TRANEXAMIC ACID TRANYLCYPROMINE, ITS SALTS TRAZODONE TRETINOIN TRIFLUPERAZINE TRIFLUPERIDOL HYDROCHLORIDE TRIFLUSAL TRIMETAZIDINE DIHYDROCHLORIDE TRIMIPRAMINE TRIPOTASSIUM DICITRATE BISMUTHATE TROMANTADINE HYDROCHLORIDE 519. 520. 521. 522. 523. 524. 525. 526. 527. 528. 529. 530. 531. 532. 533. 534. 535. 536. UROKINASE VALSARTAN VASOPRESSIN VECURONIUM BROMIDE VENLAFAXINE HYDROCHLORIDE VERAPAMIL HYDROCHLORIDE VERTEPORFIN VINCRISTINE SULPHATE VINBLASTINE SULPHATE VINDESINE SULPHATE VINORELBINE TATRATE XIPAMIDE ZIDOVUDINE HYDROCHLORIDE ZIPRASIDONE HYDROCHLORIDE ZOLEDRONIC ACID ZOLPIDEM ZOPICLONE ZUCLOPENTHIXOL

Note:- 1. Preparations exempted under proviso to para 2 of Note to Schedule X shall also be covered by this Schedule. 2. The salts, esters, derivatives and preparations containing the above substances excluding those intended for topical or external use (except ophthalmic and ear / nose preparations containing antibiotics and/ or steroids) are also covered by this Schedule. The inclusion of a substance in this Schedule does not imply or convey that the substance is exempted from the provisions of Rule 122A/122B. [No. X-11014/3/2004-DMS & PFA] RITA TEOTIA, Jt. Secy. Foot Note- The Principal Rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21.12.1945 and last amended vide No. G.S.R. 790 (E) dated 29.10.2009. -------------------------

3.